SUNY Downstate Medical CenterInstitutional Review Board
Please seeIRB Electronic Submissions Website (click link) for submission requirements.
NOTE: Please use the latest version of forms available on the above site. The IRB will generally accept previous versions of forms, provided they were available on the IRB website at least 3 months prior to the submission date.
CAUTION: This application is for research that is submitted for IRB approval that will be granted on or after January 19, 2018, based on a new IRB-01 policy (click link)which is scheduled to go into effect on January 19, 2018. The policy was revised to include revisions to the Exemption Categories in the Common Rule (Title 45 CFR part 46). Please note that the White House and HHS Office for Human Research Protections are in the process of going through a formal rule making process to delay the compliance date for the revised Common Rule. If the Federal Government implements any new regulations prior to the compliance date of January 19, 2018, we anticipate that we may need to make additional revisions to the IRB-01 policy or this form. If the implementation of the Common Rule is delayed, the IRB may be required to make determinations on whether a study meets the criteria for an exemption under the regulations that were in effect prior to January 19, 2018 (as described on the previous version of this form).
WARNING: This form cannot be used for research that is funded by the US Department of Justice, as they are not signatories to the revised Common Rule. The previous “IRB Application for Exempt Review” form should be used for any DOJ funded research.
1)GENERAL INFORMATION
NOTE: IF ANY INFORMATION (EXCEPT ABSTRACT) INTHIS SECTION CHANGES AFTER INITIAL IRB APPROVAL, THE PI MUST SUBMIT AN AMENDMENT TO THE IRB.
a)Protocol Title:
OPTIONAL: Please list the IRB# of any similar or associated research projects that have been approved by the SUNY Downstate IRB. Listing such projects will inform IRB Members of past research and may help the review process.
b)Scientific Abstract (OPTIONAL):
Lay Person Abstract (REQUIRED): Please provide a summary of the study for a non-scientific reader. Use non-scientific lay language and eliminate or explain any scientific terms.
c)Principal Investigator (PI):PI Contact Information:
PI Phone # (required):
PI Email (required):
Alternate PI E-mail (optional): / Dept:
Check PI Status below (check all that apply):
(1)Faculty Member at SUNY Downstate who is a sseasoned investigator with a field-specific terminal degree
(2) Clinician with privileges at NYC H+H, Kings CountyREMINDER: STAR approvalis also required for all NYC H+H research.
(3) Faculty member under recruitment to SUNY Downstate. Written memo or e-mail from a Dean is attached.
(4) Approved to be a PI by the Downstate Institutional Official (IO). Written memo or e-mail from the IO is attached.
(5) Qualify to be a PI at an external site AND this activity makes Downstate engaged (check all that apply):
Federal funding or support is provided to Downstate
Co-investigators or key personnel are (check all that apply):
Employee(s) of SUNY Downstate
Resident(s) or Fellow(s) trained under a GME program affiliated with SUNY Downstate
Student(s) in a Downstate Academic Program
d)(OPTIONAL) If someone, other than the PI, will be the main contact for this study, please provide his/her contact information below:
Name (if not PI):
Role on Study: / Phone: Email:
e)(OPTIONAL) If multiple Principal Investigators will be responsible for the scientific and technical direction for this study, complete the table below.
Rationale for using a multiple PI approach:
NOTE: Each PI must e-sign the initial IRB submission in IRBNet. The first PI listed in the IRB application will serve as the contact PI.
Additional PI Name / PI Status (for coding, see #s above) / Contact Information / Description of the roles, responsibilities and the working relationship to the primary PI.
(1), (2),(3),
(4),(5) / Phone #
Email :
(1), (2),(3),
(4),(5) / Phone #
Email :
(1), (2),(3),
(4),(5) / Phone #
Email :
Attach additional sheets if needed.
f)Who is providing funding for this study? (Check all that apply):
Downstate Department: Specify Department:
Note: Check if using departmental funds, equipment, resources, or labor.
NYC +HH, Kings County REMINDER: STAR approvalis also required for all NYC H+H research.
Note: Check if using departmental funds, equipment, resources, or labor.
Industry Sponsor: Specify funding entity: Sponsor Award #:
Federal Sponsor. Provide additional information below:
Specify agency:
Investigator initiated? Yes No
Federal Award #
GCP training complete? Yes No
Check one: Grant materials are included for congruency review. Grant materials are pending-we are requesting “conditional approval”.
NOTE: The IRB will review the federal grant materials for congruency and issue a confirmation in the final IRB Approval letter, which the PI must submit to Pre-Awards for processing.
Inbound Subcontract (Specify funding entity): Date of anticipated funding:
Other: Specify:
g)What is the status of funding?
This project is fully funded.
Project is partially funded at this time. List approved sources of funding:
Pending: Potential sources: Date of anticipated funding:
2) TABLE OF STUDY STAFF:
For training and conflict of interest disclosure requirements see:
a.Name & degree / b.
Role(s) on Project. Examples: Principal Investigator, Co-Investigator, Coordinator, Consultant, Fellow, Resident, Student, Research Staff, Healthcare Operations only, Access to de-identified data only, Specimen shipment, etc. / c.
Place of employment
REMINDER: STAR approvalis also required for all NYC H+H research. / d.
Will this person be obtaining verbal or written Informed Consent/Authorization / e.
Is this person an “Investigator for the purposes of COI reporting”?
FEDERALLY FUNDED STUDIES ONLY: THE PI IS ALWAYS CONSIDERED AN INVESTIGATOR FOR COI PURPOSES. / f.
Will this person aid the shipment of hazardous materials (e.g., dangerous goods, specimens) to be transported by a public carrier?
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
a.
Name & degree / b.
Role(s) on Project. Examples: Principal Investigator, Co-Investigator, Coordinator, Consultant, Fellow, Resident, Student, Research Staff, Healthcare Operations only, Access to de-identified data only, Specimen shipment, etc. / c.
Place of employment
REMINDER: STAR approvalis also required for all NYC H+H research. / d.
Will this person be obtaining verbal or written Informed Consent/Authorization / e.
Is this person an “Investigator for the purposes of COI reporting”?
FEDERALLY FUNDED STUDIES ONLY / f.
Will this person aid the shipment of hazardous materials (e.g., dangerous goods, specimens) to be transported by a public carrier?
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
SUNY Downstate
NYC +HH, KC
Other: / Yes No / Yes No / Yes No
Attach additional pages if needed.
3) PROPOSED EXEMPTION(S):
An exempt determination may be made by the IRB if all of the activities of the proposed study meet the conditions for exempt human research of one or more of the categories outlined below.
Note: SUNY Downstate does not have procedures in place to permit IRB approval of Common Rule Exemption Category 7 [45 CFR 46.104 (d)(7)] or Common Rule Exemption Category 8 [45 CFR 46.104 (d) (8)].
Do ALL of the activities for this research meet the specific criteria of one or more categories outlined within the exemption research categories outlined below?
Yes No If no is checked, do not use this form, as the research will not qualify as “exempt” research.
Is this research subject to NYS Article 24A?
Refer to IRB-01 Policy or contact the IRB for help making this determination.
Yes No If no is checked, do not use this form, as the research will not qualify as “exempt” research.
Is this research federally supported (e.g., funded)or conducted?
Yes No
If Yes is checked above, please check the box(es) below to indicate if any of the following vulnerable populations are involved:
Pregnant women or fetuses. Exemptions can be applied.
Children (including neonates):
Note: Federally supported or conducted research involving children cannot be exempt unless noted below.
Prisoners:
Note: Federally supported or conducted research involving prisoners does not qualify as “exempt.”
A broadresearch participant population that might only incidentally include prisoners. Exemptions can be applied.
Does the research involve Protected Health Information (PHI)?
Yes No
If Yes, which HIPAA instrument is included:
HIPAA research authorization
HIPAA waiver
Data Use Agreement (DUA)
Business Associates Agreement (BAA)
In the sections below, please check the Exemption Category(ies) which are proposed for this project and answer any questions related to each category that is checked.
Common Rule Exemption Category 1 [45 CFR 46.104 (d)(1)]:
Research, conducted in established or commonly accepted educational settings that specifically involve normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Complete the following if the above box was checked:
Describe the established or commonly accepted educational setting:
Describe the normal educational practice:
Describe the reasons why this activity is is not likely to adversely impact the students’ opportunity to learn required educational content:
Describe the reasons why this this activity is not likely to adversely impact the assessment of educators who provide instruction:
Please provide any additional information for the IRB to consider:
Common Rule Exemption Category 2 [45 CFR 46.104 (d) (i), (ii), or (iii)]:
Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
1) The information obtained is recorded by the investigator in such a manner that the identity of the research participants cannot readily be ascertained, directly or through identifiers linked to the research participants;
2) Any disclosure of the research participants’ responses outside the research would not reasonably place the research participants at risk of criminal or civil liability or be damaging to the research participants’ financial standing, employability, educational advancement, or reputation;
3) The information obtained is recorded by the investigator in such a manner that the identity of the research participants can readily be ascertained, directly or through identifiers linked to the research participants.
If the above box was checked, check the box to indicate the research onlyincludes one or more of the following:
Interactions involving educational tests (cognitive, diagnostic, aptitude, achievement)
Survey procedures
Interview procedures
Observation of public behavior (including visual or auditory recording)
Which criteria apply to this research?
Criteria 1:[45 CFR 46.104 (d)(2)(i)]: The information obtained is recorded by the investigator in such a manner that the identity of the research participants cannot readily be ascertained, directly or through identifiers linked to the research participants;
- This exemption may only be applied to federally supported or conducted research involving children (including neonates) that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed.
Criteria 2:[45 CFR 46.104 (d)(2)(ii)]: Any disclosure of the research participants’ responses outside the research would not reasonably place the research participants at risk of criminal or civil liability or be damaging to the research participants’ financial standing, employability, educational advancement, or reputation;
- This exemption may only be applied to federally supported or conducted research involving children (including neonates) that involves educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed.
Criteria 3:[45 CFR 46.104 (d)(2) (iii)]: The information obtained is recorded by the investigator in such a manner that the identity of the research participants can readily be ascertained, directly or through identifiers linked to the research participants.
- This exemption may not be applied to federally supported or conducted research involving children (including neonates).
- Limited IRB review must take to ensure there are adequate provisions to protect the privacy of research participants and to maintain the confidentiality of the data.
If the box above is checked for Criteria 3, please describe the provisions to protect the privacy of research participants and for maintaining the confidentiality of the data:
Please provide any additional information for the IRB to consider:
Common Rule Exemption Category 3 [45 CFR 46.104 (d)(3) (i) (A or B or C) or (ii) or (iii)]:
NOTE: This exemption cannot be applied to federally supported or conducted research that involves children (including neonates)
Research involving benign behavioral interventions in conjunction with the collection of information from an adult research participant through verbal or written responses (including data entry) or audiovisual recording if the research participant prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
- The information obtained is recorded in such a manner that human research participants cannot be identified, directly or through identifiers linked to the participants; or
- Any disclosure of the human research participants' responses outside the research could not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, educational advancement or reputation; or
- Information obtained is recorded in such a manner that human research participants can be identified, directly or through identifiers linked to the participants.
For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the research participants, and the investigator has no reason to think the research participants will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the research participants play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
If the research involves deceiving the research participants regarding the nature or purposes of the research, this exemption is not applicable unless the research participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the research participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Complete the following if the above box was checked:
Describe the benign behavioral intervention(s):
How is information collected from adults (18 years of age) research participants?
Verbal or written responses (including data entry)
Audiovisual recording
Describe the process for obtaining the participants prospective agreement to the intervention and information collection:
Please confirm that the benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the research participants, and the investigator has no reason to think the research participants will find the interventions offensive or embarrassing.
Confirm by checking box. If this box is not checked, the research does not qualify for this exemption.
Does this research involve deceiving the research participants regarding the nature or purposes of the research?
Yes No
If yes is checked, this exemption is not applicable unless the research participant authorizes the deception through a prospective agreement to participate in research in circumstances in which the research participant is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
Include a copy of the agreement with this submission.
Which criteria apply to this research?
Criteria 1:[45 CFR 46.104 (d)(3) (i) (A)]: The information obtained is recorded in such a manner that human research participants cannot be identified, directly or through identifiers linked to the participants; or
Criteria 2:[45 CFR 46.104 (d)(3) (i) (B)]: Any disclosure of the human research participants' responses outside the research could not reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, educational advancement or reputation; or
Criteria 3: [45 CFR 46.104 (d)(3) (i) (C)]: Information obtained is recorded in such a manner that human research participants can be identified, directly or through identifiers linked to the participants.
Note: Limited IRB review must take place for exempt research approved under Criteria 3 [45 CFR 46.104 (d) (3) (i) (C)] to ensure, when appropriate, there are adequate provisions to protect the privacy of research participants and to maintain the confidentiality of the data.
If the box above is checked for Criteria 3, please describe the provisions to protect the privacy of research participants and for maintaining the confidentiality of the data:
Please provide any additional information for the IRB to consider:
Common Rule Exemption Category 4[45 CFR 46.104 (d)(4) (i) or (ii) or (iii) or (iv)]:
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
- The identifiable private information or identifiable biospecimens are publicly available;or
- Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the research participants cannot readily be ascertained directly or through identifiers linked to the research participants, the investigator does not contact the research participants, and the investigator will not re-identify research participants;or
- The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
- The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
Complete the following if the above box was checked: